Fake medicines pose health risks, economic costs; India fails to act

Last week, two pieces of news were widely reported by most Indian media outlets. The first was that a case had been registered against a group of people who were supplying fake drugs — including antibiotics — to government hospitals in Maharashtra, Chhattisgarh, Uttar Pradesh and Jharkhand. The pills and tablets supplied were mostly composed of talcum powder and starch. There were no active pharmaceutical ingredients or formulations in them at all.

Almost immediately after this news was reported, another equally worrying piece of news emerged. A recent survey by the Central Drugs Standard Control Organisation (CDSCO) found that 50 commonly used medications available in the market — including prominent antibiotics, antacids, antipyretics and antihypertensives — were substandard. Some of these drugs mentioned in the survey were marketed and/or manufactured by fairly prominent drug firms, including Hindustan Antibiotics, Alkem, Torrent and several others. A few of the brand samples that failed the test were market leaders in their respective categories.

State drug officers in India conduct random sampling of medicines available in the market every month — and the CDSCO has consistently found many drugs tested from these samples to be substandard. This was not the first report saying multiple samples had been found to be substandard — though it was more detailed than similar reports that had appeared earlier.

Substandard and fake drugs are not a problem in India alone. Some years ago, the World Health Organization (WHO) estimated that one in 10 medical products (mostly drugs or vaccines but also medical devices) circulating in lower- and middle-income countries falls into the substandard or “falsified” category. (India is in the lower middle-income-nation cohort because of its current per capita income.) Even developed or more accurately high-income nations face this problem but to a lesser degree.

Substandard and falsified drugs have a major impact on the country’s economic productivity and growth for multiple reasons, and various studies have been conducted in countries across Asia, Latin America and Africa to assess these impacts. Surprisingly, there are no detailed, large-sample studies in India on this subject. Still, the reasons substandard and falsified drugs have such a big impact on the economy are well-known. These drugs are ineffective in curing diseases and may prolong the time required for treatment, or even cause death. This, in turn, results in increased healthcare costs and lost work days. It may lead to job losses and higher personal debt incurred for healthcare expenses. In a country where much of the population is just one hospitalisation away from poverty, this invariably pushes more people into the ranks of the poor. Substandard drugs can lead to higher mortality at all ages, but particularly among infants and the elderly. It can also lead to long-term healthcare dangers, such as large-scale antimicrobial resistance in populations.

And while all low- and middle-income countries may face this problem, India faces a bigger problem for a couple of reasons. The first is because of the size of the Indian population. As the world’s most populated country, according to United Nations estimates, the problems tend to get magnified in India. At a time when India needs to capitalise on its “demographic dividend”, substandard and fake drugs can reduce the country’s gross domestic product (GDP) growth rate far below its potential.

Over the decades, India has worked hard to earn the title of “pharmacy to the world” because of its prowess in generics and low-cost vaccines. The increasing prevalence of substandard and falsified medicines can make countries wary of importing Indian drugs, allowing competitors to grab a chunk of the market. Yet little effort has been made to combat the problem. Even when manufacturers are caught producing or supplying substandard drugs, they are rarely punished. If they do get any punishment, it is typically a fine of just a few thousand rupees, which they are happy to pay. There is no action by regulatory authorities to recall all drug batches found to be defective.

More importantly, two problems are at the core of substandard and falsified drugs in India. The first is regulatory capacity. The CDSCO relies on state officials to a large extent, but most states have not developed significant capacity or expertise in checking samples, testing them, ensuring that drug firms adhere to good manufacturing practices, and taking action against errant manufacturers.

The second issue is that much of India’s drugs — even those sold by big pharma companies — are manufactured by small-scale contract manufacturers with lax quality control and without the wherewithal to invest in instruments needed for quality control and testing.

Both these issues can be sorted out — if the Union and state governments are willing to do so. Unfortunately, Indian policymakers have always accorded low priority to healthcare — whether it involves building state capacity and infrastructure or enacting strict laws to punish wrongdoers.

The fact that multiple studies across the world have shown that substandard and falsified medicines have significant economic costs to a nation has been largely ignored by Indian policymakers. This attitude will need to change if India is serious about escaping the middle-income trap and joining the ranks of high-income nations — even three or four decades from now.

The writer is former editor of Business Today and Businessworld, and founder of Prosaic View, an editorial consultancy